The FDA approved U-Systems' Somo•v breast ultrasound system, the only automated system in the U.S., Canada and 27 European Union countries indicated for use in combination with standard mammography for asymptomatic women with dense breast tissue.

Dense breast tissue, which occurs in nearly half of women, increases the risk of breast cancer up to 4-to-6 times and can also make the cancer more difficult to detect with mammography, some studies have shown.

GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.

The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.